Method for analyzing heart rate variability, apparatus and use thereof

a heart rate variability and analysis method technology, applied in the field of methods and apparatus for analyzing heart rate variability, can solve the problems of large individual differences in efficacy of drug treatment, high uncertainty, and patient resistance to drug treatment, and achieve efficient screening, save unnecessary expenditures, and accurate results

Active Publication Date: 2021-10-26
BEIJING PINS MEDICAL +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0009]Based on this finding, low-cost, portable and wearable signal acquisition equipment is adapted in the present invention, thus 24-hour ECG signals of an epileptic before surgery could be acquired. A multiscale entropy (MSE) of ECG could be calculated through a programmed HRV analysis, wherein characteristic parameters representing heart rate complexity are extracted on the basis of an MSE curve, and a drug refractory epileptic suitable for VNS surgery could be accurately and efficiently screened, thus saving unnecessary expenditures and avoiding delaying the optimal timing for treatment. At the same time, a patient suitable for VNS surgery is clearly selected through characteristic parameters of ECG's MSE heart rate complexity, which could generally improve the efficacy of VNS therapy.

Problems solved by technology

However, some patients are still not sensitive to drug treatment.
However, the individual differences in efficacy thereof are very large and uncertainties are pretty high.
At present, there has been no definitive screening method for VNS surgical indications clinically applied.
The existing EEG and MRI methods have disadvantages of high cost, complicated operations, and high requirements on professional knowledge.
Overall, studies based on these methods have not been clinically applied.
To date, there have been no studies and technical solutions for screening VNS patients using electrocardiographic signal HRV analysis technology.

Method used

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  • Method for analyzing heart rate variability, apparatus and use thereof
  • Method for analyzing heart rate variability, apparatus and use thereof
  • Method for analyzing heart rate variability, apparatus and use thereof

Examples

Experimental program
Comparison scheme
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example 1

[0040]As shown in FIG. 2, a standard 12-lead ECG acquisition for 24 hours before surgery requires: sampling frequency of the ECG acquisition device is greater than or equal to 500 Hz; during ECG recording, activities such as strenuous exercises and medications that could affect cardiac functions should be avoided; the recording period is 24 hours. Recording environment and conditions of subjects should be basically similar. The data used for HRV analysis should be ensured to be normal sinus NN intervals. During HRV analysis, normal sinus NN intervals of 4 hours are selected for MSE analysis from the 24-hour long-term ECG records during which the subject is in an awake state. The specific processing flow of ECG signals is shown in FIG. 3.

[0041]1) collecting and digitizing ECG signals;

[0042]2) denoising and de-articulating digital signals;

[0043]3) automatically detecting QRS waves thereof;

[0044]4) manually inspecting QRS waves of the detected signals;

[0045]5) removing ectopic exciting...

example 2

[0063]The complexity indicator Area 6-n, when the scale factor in the MES analysis method of Example 1 is expanded to n, could also be used for screening VNS patients as described above.

[0064]In the present invention, for patients with drug refractory epilepsy, preoperative electrocardiogram acquisition 24 hours before surgery and the MSE analysis of HRV were performed. In this way, patients with drug refractory epilepsy could be screened before surgery, thereby guiding patients who are not eligible for VNS therapy not to receive the surgery and choose other therapies, which could save unnecessary expenditures and avoiding delaying the optimal timing for treatment. Meanwhile, patients with VNS surgical indications were clearly selected by extracting characteristic parameters representing heart rate complexity through ECG's MSE curve, which could improve overall VNS therapeutic efficacy.

example 3

[0065]In accordance with the above screening method, 32 patients with medical refractory epilepsy, who had undergone VNS surgery at Beijing Tiantan Hospital from Aug. 13, 2014 to Dec. 31, 2014, were selected for test. Before VNS surgery, these 32 patients with medical refractory epilepsy were comprehensively evaluated (including demographic characteristics, clinical history, history of antiepileptic medication, 24-hours video-EEG, MRI, and 24-hour dynamic electrocardiogram etc.).

[0066]According to the above ECG signal processing method, the MSE analysis was performed, based on 24-hour dynamic electrocardiographic data. The corresponding characteristic parameters Slope5, Area1-5, Area6-15, and Area6-20 were extracted based on each patient's MSE curve. At the end of 1-year follow-up, among 32 patients with drug refractory epilepsy who had undergone VNS treatment, 28 patients' seizure frequencies had been reduced to various degrees (seizures had been completely controlled in 6 patients...

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Abstract

A method for analyzing heart rate variability, and an apparatus and use thereof, the method for analyzing heart rate variability including collecting ECG data in vitro; digitizing and denoising the ECG data; forming the processed ECG data into a sinus NN interval sequence; selecting sinus NN interval data of 4 hours in an awake state; performing MSE calculation on the sinus NN interval sequence of 4 hours in an awake state; and extracting parameters representing the complexity of a heart rate by using MSE curves. The present invention may provide accurate and efficient screening for drug-refractory epilepsy patients who are suitable for vagus nerve stimulation surgery, thus avoiding unnecessary expenses, and avoiding missing the most opportune moment for treatment. At the same time, patients suitable for VNS surgery are selected by using MSE complexity feature parameters of ECG, thus improving the overall efficacy of VNS therapy.

Description

TECHNICAL FIELD[0001]The invention relates to a method and an apparatus for analyzing heart rate variability and use thereof, in particular to a method for analyzing heart rate variability for patients with Vagus Nerve Stimulation (VNS) indications.BACKGROUND[0002]Epilepsy as a disease affects the lives of patients. For most patients, epileptic seizures could be controlled by one or more drugs. However, some patients are still not sensitive to drug treatment. These patients are called patients with drug refractory epilepsy. As an adjuvant therapy, Vagus Nerve Stimulation (VNS) can effectively control epileptic seizures in patients with drug refractory epilepsy. However, the individual differences in efficacy thereof are very large and uncertainties are pretty high. Statistical analysis shown that, epileptic seizures were completely relieved in only 5% to 9% of patients with drug refractory epilepsy who were treated with VNS surgery, about 10% of patients were completely ineffective,...

Claims

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Application Information

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Patent Type & Authority Patents(United States)
IPC IPC(8): A61B5/024A61B5/00A61B5/0245A61B5/282A61B5/318A61B5/352A61B5/364
CPCA61B5/7278A61B5/0245A61B5/02405A61B5/02438A61B5/282A61B5/318A61B5/352A61B5/4064A61B5/4094A61B5/6823A61B5/7275A61B5/7235A61B5/364G16H50/30
Inventor LI, LUMINGLIU, HONGYUNYANG, ZHAO
Owner BEIJING PINS MEDICAL
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